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Do you develop or implement a new medical technology?

Medical technologies require constant improvements and innovations, including research and development, close co-operation with patients, health care providers and payers. These specific characteristics of medical technology industry imposes a need for detailed assessments and qualified decision making. No matter whether you need to convince an internal board, your investors or a public funding body, the systematic evaluation of economic and social impacts provides evidence for decision making.

To commercialise a new medical device, it is essential to be fully compliant with regulatory requirements and it is needed to prepare a medical device conformity assessment process.

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SERVICES How we can help
Health Technology Assessment
The reimbursement environment is constantly changing. Requirements vary between markets and they need coordination across multiple areas to produce high-quality results. To help clients to achieve market access, our experts across our health economics, regulatory affairs and business modelling help with preparing relevant reports.
HTA model refers to the systematic evaluation of properties, effects,and/or impacts of health technology to evaluate the social, economic, organizational, and ethical issues of a health intervention or health technology. HTA Framework will follow EU HTA Regulation 2021/2282 on health technology assessment and amending Directive2011/24/EU to enable production of high quality HTA information instructured format.
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Decision-analytic Models
We offer experience in modeling methods and advise clients on thebest methodology given defined objectives.

We prepare these models:
• Cost-effectiveness analysis, Cost-utility analysis, Cost-benefit analysis
• Budget impact models
• Cost-consequence analyses
• Asset valuation models
• Value-based pricing models
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Cost Benefit Analysis
Is your strategic plan, project or task that you are currently solving associated with complex impacts which affect various entities and subjects?
The CBA method evaluates the effects of investment decisions on all actors involved. The advantage of using this method is that the benefits, but also the costs (negative impacts) do not necessarily have to be expressed only in money, but also expressed by qualitative parameters (for example, in the form of social, environmental or other qualitative metrics). We choose a suitable method and convert advantages into financial values. Then, the impacts can be effectively assessed.
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Budget Impact Analysis
Wondering how the use of resources will change after the launching of new technology on the market? What impact will a new treatment intervention have on the budget of stakeholders? By understanding the treatment effect and the target population, knowledge of its size, incidence and prevalence of the disease or the number of hospitalizations or outpatient care associated with the disease, we evaluate the impact of new technology on public or insurance budgets.
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New Technologies and Business Modelling
An analysis of acceptance of new technology by target groups (users, patients, public authorities, management of publicinstitution) is performed. Designed customer questionnaire sallows to model particular market situation and there commendation for wider acceptance is provided.

We can also offer preparation some model od commercialization (IP, licensing etc.). Market size, customer characterization, ability or willingness to pay, current state of the market and active competitors and their products are key input for business and cash flow modelling. Comprises key part of Business Model Canvas tool helps with capturing and organizing key aspects of your business idea. This helps to clarify business model and create a clear plan for a venture. In combination with system dynamics modelling method, result is a business model quantified in the form of system dynamics, which will supply cashflows for valuation according to founders or investors assumptions and translate them into exact valuation scenario immediately.

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Literature Review and Meta-analyses
We conduct literature reviews and meta-analyses using the mostrigorous methodologies, to deliver reliable and reproducible answers to client’s research questions. High-quality literature reviews help tounderstand:

• Epidemiologic, humanistic, and economic burden of a disease
• Treatment guidelines and patterns in clinical practice
• Clinical and cost-effectiveness of comparator treatments
• Best practices in economic modelling methods in a disease area
• Economic model inputs including resource use, cost, and utility estimates

These results may be used as supplemental evidence as input to economic models, or in some cases, to support HTA submissions.
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Regulatory Affairs for Medical Devices
In the dynamic realm of medical technology, where innovation is key, we understand that success hinges on a meticulous approach. From research and development to collaborating closely with patients, healthcareproviders, and payers, the medical technology industry demands thorough assessments andinformed decision-making.
Whether your goal is to gain internal buy-in, secure investments, or attract public funding,our systematic evaluation of economic and social impacts offers compelling evidence foryour decision-making needs.
When it comes to bringing a new medical device to market, strict adherence to regulatory requirements is paramount. Our services encompass every facet of the medical device conformity assessment process:

• Regulatory strategy and CE mark of conformity
• Technical documentation and compliance
• Quality management system (QMS) implementation
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Regulatory strategy and CE mark
Embark on your journey to market dominance with our Regulatory Strategy and CE Mark of Conformity service.

We thoroughly analyze your regulatory needs, providing a comprehensive view of available options for compliance and market access.
We excel in navigating conformity assessments, acting as your reliable liaison with notified bodies, ensuring you’re never alone in your regulatory journey.

Our Regulatory Strategy assessments extend beyond borders, covering EU MDR Regulation (EU) 2017/745, FDA guidelines, and more, allowing you to expand your market confidently.
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Technical Documentation and Compliance
We enhance your medical device’s potential through our Technical Documentation and Compliance services:

• Ensuring compliance with international standards and MDCG guidelines, making GSPR (General Safety and Performance Requirements) adherence effortless
• Covering a wide range, from usability analysis (IEC 62366-1) to pre-clinical and biological evaluation (ISO 10993-1), including technical safety evaluation(IEC 60601-1), risk analysis (ISO 14971), user manuals, software descriptions (IEC 62304), clinical evaluation, post-market clinical follow-up, and vigilance
• Comprehensive assessment of your testing needs, including electrical, biological, and clinical safety testing. We also consider retesting requirements, ensuring you stay ahead of evolving standards
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Quality Management System
We offer end-to-end QMS implementation, covering everything from interviews to ISO 13485-compliant processes:

• Personalized approach: We begin with individual interviews to create QMS processes tailored to your unique needs
• Optimization focus: Our goal isn’t just implementation; we aim to maximize efficiency, ensuring your QMS processes are not only compliant but also optimized for superior performance
• ISO 13485 alignment: Our expertise ensures seamless alignment with ISO13485 standards, giving you a competitive edge through internationally recognized quality management practices
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